Abstract
BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEMIGLIPTIN TARTRATE SESQUIHYDRATE.

Shailesh V. Luhar*, Harshi A. Patel, Dr. G. K. Jani and Dr. P. Malairajan

ABSTRACT

A simple, selective, specific, accurate Liquid Chromatography -Mass Spectrometry (LC-MS) method was developed and validated for the determination of Gemigliptin in Human Plasma. The accuracy and precision data must fulfill the requirements for the quantification of analytes in biological matrices to produce data for bioavailability, bioequivalence, etc. The separation of the analyte was carried out on Phenomenex Gemini C18 , (3 μm, 30.0 × 2.0 mm) column and the mobile phase containing 0.1% Formic acid in 10 mM Ammonium acetate in water : Acetonitrile (10:90% v/v) at a flow rate of 0.5 mL/min. The retention times of Gemigliptin and Sitagliptin (Internal Standard) were 3.29 min and 4.22 min simultaneously and the total run time was 5.5 min. Monitoring of the fragmentation of m / z 490.160 → 338.100 and 408.142 → 235.000 performed during MS/MS detection of Gemigliptin and Internal Standard (I.S.) on the mass spectrometer. The overall recovery of Gemigliptin and IS was 89.81% and 89.52% respectively. The method was validated over the concentration range of 1 ng/mL to 2000 ng/mL. The method was validated for linearity, accuracy, precision, specificity, selectivity, inter and intraday precision, LQC, HQC.

Keywords: Gemigliptin, LC-MS, Bioanalytical Method, validation.


[Full Text Article]

Login





Forgot Password  |  Register

Indexing

Best Paper Awards

European Journal of Biomedical and Pharmaceutical Sciences (EJBPS) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.

Best Article of current issue :

Dr. Dhrubo Jyoti Sen

Download Article : Click here

News & Updation

  • EJBPS: FEBRUARY ISSUE PUBLISHED

    FEBRUARY 2023 Issue has been successfully launched on 1 FEBRUARY 2023.

  • EJBPS New Impact Factor

    Its our Pleasure to Inform you that EJBPS Impact Factor has been increased from 5.467 to 6.044, due to high quality Publication at International Level.

  • Index Copernicus Value

    EJBPS Received Index Copernicus Value 77.3, due to High Quality Publication in EJBPS at International Level

  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.

    .

  • Article Invited for Publication

    Dear Researcher, Article Invited for Publication  in EJBPS coming Issue.

     

UG/PG/Ph.D Research Publication

Research Scholar of UG/PG/Ph.D can Submit their Research Article/Review Article/Case Study/Short Communication for Publication in EJBPS

Downloads

Copyright From

Covering Letter

                        Author Instruction 
 

PLAGERLUM REPORT